Phase 2
N=4
ACY-7 Oral Administration of Acyline
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00603187 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Testosterone Blood Serum Concentration — 14.25; 8.53; 9.83; 9.83 ng/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acyline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Testosterone Blood Serum Concentration |
14.25; 8.53; 9.83; 9.83; 10.10; 9.50 | — |
| SECONDARY FSH Blood Serum Concentration |
2.80; 2.05; 2.33; 2.23; 2.48; 2.38 | — |
| SECONDARY LH Blood Serum Concentration |
4.87; 2.73; 4.78; 4.15; 5.80; 5.18 | — |
Summary
We propose oral dosing of gastrointestinal permeation enhancement technology [GIPET] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.
Eligibility Criteria
Inclusion Criteria
- Healthy male
- 18-50 years of age
- Non-smoker
- Not taking any medications other than the study drug for the duration of the study.
- Must be willing to use an accepted method of contraception during the study.
Exclusion Criteria
- BMI > 35
- Abnormal evaluation on screening exam and labs
- Known history of alcohol abuse, illicit drugs or steroids and/or use of more that 3 alcoholic beverages/day
- History of current testosterone use or infertility
- History of testicular disease or severe testicular trauma
- History of major psychiatric disorder or sleep apnea
- History of bleeding disorder or need for anticoagulation
- Current smoker or utilizing nicotine patches or gum
- Participation in a hormonal drug study within past month.
Data sourced from ClinicalTrials.gov (NCT00603187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.